Diagnostic accuracy of prostate-specific antigen and prostate-specific antigen density in patients suspected of having prostate cancer in South Korea: A large, multi-institutional registry.

PURPOSE: Owing to concerns about overdiagnosis and overtreatment associated with prostate-specific antigen (PSA) screening for early prostate cancer detection, recent guidelines have lowered the PSA cutoff value for recommending biopsy. This study aimed to evaluate the diagnostic accuracy of a lower PSA cutoff value in Korean men and to explore whether additional clinically useful criteria can be proposed. MATERIALS AND METHODS: A retrospective cohort study of 17,539 Korean men who underwent their first prostate biopsy due to lower urinary tract symptoms was conducted at six tertiary hospitals between 2011 and 2019. The diagnostic performance of various PSA and PSA density (PSAD) cutoff values across age groups was evaluated by analyzing the data on demographics, PSA levels, PSAD, and biopsy results. RESULTS: Among the participants, 44.1% were diagnosed with prostate cancer, of whom 73.7% had clinically significant cancer (Gleason score ≥7). No significant differences in cancer detection rates were found between PSA levels of 3-4 ng/mL and 4-5 ng/mL across age groups. PSAD further increased the area under the receiver operating characteristic curve by 5.5%-11.4%. CONCLUSIONS: These findings suggest that diagnostic yield may not be impacted by merely lowering the PSA cutoff. Rather, combining PSA, PSAD, and patient age enhances screening accuracy while minimizing unnecessary biopsies and overdiagnosis. Our results highlight the need for more data to refine national screening guidelines and promote a more tailored approach to prostate cancer screening in Korea.